Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-05 @ 1:16 AM
Study NCT ID:
NCT03433859
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077410', 'term': 'Aluminum Chloride'}, {'id': 'D003358', 'term': 'Cosmetics'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperhidrosis Disease Severity Score (HDSS) evolution', 'timeFrame': '24 weeks', 'description': 'HDSS score : min 1 - max. 4\n\n* Efficacy : HDSS evolution from 2 (initial measure) to 1 (final measure), from 3 (initial measure) to 1 or 2 (final measure), from 4 (initial measure) to 1 or 2 (final measure)\n* Failure : from 2 (initial measure) to 2 (final measure), from 3 or 4 (initial measure) to 2 (final measure) ; or increase of HDSS between initial and final measure'}], 'secondaryOutcomes': [{'measure': 'Mismatch of prothesis associated with sweat measured by a visual analogue scale', 'timeFrame': '3 years', 'description': 'Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \\> 50% increase between initial and final measure'}, {'measure': 'Problems with walking due to sweat measured by a visual analogue scale', 'timeFrame': '3 years', 'description': 'Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \\> 50% increase between initial and final measure'}, {'measure': 'Sweat quantity measured by a visual analogue scale', 'timeFrame': '3 years', 'description': 'Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \\> 50% increase between initial and final measure'}, {'measure': 'Quality of life measured by a visual analogue scale', 'timeFrame': '3 years', 'description': 'Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if \\> 50% increase between initial and final measure'}, {'measure': 'Amount of time spent wearing the prothesis', 'timeFrame': '3 years', 'description': 'Amount of time spent wearing the prosthesis (hours per day): efficacy if increase'}, {'measure': 'Prothesis removed to dry the residual limb', 'timeFrame': '3 years', 'description': 'Number of times the prosthesis had to be removed to dry the residual limb and sleeve per day: efficacy if no need to remove it or only once a day'}, {'measure': 'Quality of life(DLQI)', 'timeFrame': '3 years', 'description': 'DLQI quality of life questionnaire : efficacy if increase'}, {'measure': 'Quality of life (physical domain of SF36)', 'timeFrame': '3 years', 'description': 'SF36 "limitations due to physical state" specific domain : efficacy if increase'}, {'measure': 'Quality of life (subjective improvement felt)', 'timeFrame': '3 years', 'description': 'Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if\\>50% increase'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperhidrosis', 'Residual Limbs']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.', 'detailedDescription': 'After randomization patients will receive either OnabotulinumtoxinA once or topical aluminium chloride for 6 months. All patients will be evaluated during 3 study visits (week 4, week 12, week 24) and 1 phone call (week 18).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower limb amputees suffering from residual limb hyperhidrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause\n* HDSS ≥ 2 (Hyperhidrosis Disease Severity Score)\n* Men and women\n* 18 to 75 years old\n* Written informed consent\n* No exclusion criteria\n* Social assurance\n\nExclusion Criteria:\n\n* Botulinum toxin injection necessity for another disease\n* Evolutive Central neurologic disease or myasthenia.\n* Egg or albumine allergy\n* Botulinum toxin or other excipients hypersensibility\n* Legally protected Adults and people unable to give an informed consent. (article L-1121-8 from Public Health Code), people without freedom and people hospitalized without consent (article L-1121-6 from Public Health Code)\n* Pregnant women or giving breast women (article L-1121-5 from Public Health)\n* Patient refusing participating\n* Previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks\n* Previous hyperhidrosis treatment with botulinum toxin in the last 2 years\n* Other ongoing hyperhidrosis treatment\n* Large residual limb eczematiform lesions: corticoids treatment (for example: Locapred® 1 application per day during 1 week then decrease).\n* Aminoglycoside ongoing treatment'}, 'identificationModule': {'nctId': 'NCT03433859', 'acronym': 'SALUTOX', 'briefTitle': 'Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)', 'orgStudyIdInfo': {'id': '2013RC09'}, 'secondaryIdInfos': [{'id': '2014-002068-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA in intradermal Injections on residual lower limb', 'interventionNames': ['Drug: OnabotulinumtoxinA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Aluminium Chloride', 'description': 'Topical Aluminium Chloride (cosmetic product) on the lower limb', 'interventionNames': ['Other: Topical Aluminium Chloride (cosmetic product)']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose', 'armGroupLabels': ['OnabotulinumtoxinA']}, {'name': 'Topical Aluminium Chloride (cosmetic product)', 'type': 'OTHER', 'description': 'Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb', 'armGroupLabels': ['Topical Aluminium Chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49103', 'city': 'Angers', 'country': 'France', 'facility': 'Les Capucins', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29240', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital Clermont-Tonnerre', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '33523', 'city': 'Bruges', 'country': 'France', 'facility': 'CMPR La Tour de Gassies', 'geoPoint': {'lat': 44.88287, 'lon': -0.61222}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '13384', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Laveran', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '35043', 'city': 'Rennes', 'country': 'France', 'facility': 'Pôle Saint Helier', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44818', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre La Tourmaline', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67082', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut Universitaire de Réadaptation Clémenceau', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '94460', 'city': 'Valenton', 'country': 'France', 'facility': "Institut Robert Merle d'Aubigné, IRMA", 'geoPoint': {'lat': 48.74527, 'lon': 2.46467}}], 'overallOfficials': [{'name': 'Hélène BISSERIEX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}